EMMES Corporation
Data Manager
EMMES Corporation, Rockville, Maryland, us, 20849
Overview
Data Manager
US Remote
Emmes Group: Building a better future for us all.
Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.
We believe the work we do will have a direct impact on patients' lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We're looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us!
Primary Purpose
The Data Manager is responsible for data management activities for research studies. The Data Manager works as an integral part of a cross-functional team through the lifecycle of the research study from design through final analysis and study closeout. The Data Manager is responsible for the completeness and accuracy of the study data in the electronic database and collaborates with internal and external project teams on all aspects of data collection.
Responsibilities
Participates with cross-functional teams in design, documentation, testing, and implementation of clinical data collection studies in an electronic data capture (EDC) systemDesigns and/or develops study-specific electronic or paper Case Report Forms (CRFs), ensuring consistency with study protocol, clinical requirements, and accurate and efficient data collectionCollaborates with the project team and other study personnel to determine data collection requirements based on the study protocol and system knowledgeDocuments and resolves data management issues for a protocol or group of protocolsAssists with communication for internal and external teams to resolve data management issuesCreates or reviews data validation check specifications; coordinates with relevant parties in the development and testing of eCRF and data validation checksHelps organize project team meetings and facilitates efficient project communication to ensure deadlines are met; participates in department meetingsCreates and maintains study data management documents according to instructions (e.g. Data Management Handbook, Data Management Plan, Data Validation Plan, EDC System User's Guide, EDC Training and Certification Documents)Prepares data reports and assists with data presentations as applicableReviews data obtained through Electronic Medical Records (EMR) integration, commercially available EDC systems, or other external data sourcesMentors assigned employees on data management procedures and guidelinesIdentifies and resolves data queries and discrepancies; contributes to data quality metrics for a protocol or project; conducts data quality auditsConducts training for users on the EDC system and protocol-specific EDC requirements; maintains training documentation and manages system user accessOther duties as assignedQualifications
Bachelor's degree, preferably in a public health, clinical, science, technical, or related discipline; equivalent combination of education and relevant work experience may be considered in lieu of a degreeIncumbent typically will possess at least 2 years of data management experience (or Master's degree) and basic understanding of the clinical development and data management processesExperience in clinical electronic data capture (EDC) systems preferredKnowledge of Microsoft Office suite is essentialAbility to handle multiple tasks at one time and to work with minimal supervisionExcellent verbal and written communication skillsStrong attention to detail, adaptable, and flexibleWhy work at Emmes?
At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our
Emmes Cares
community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:
Flexible Approved Time OffTuition Reimbursement401k Retirement PlanWork From Home Anywhere in the USMaternal/Paternal LeaveCasual Dress Code & Work Environment
CONNECT WITH US!
Follow us on Twitter - @EmmesCRO
Find us on LinkedIn - Emmes
The Emmes Company, LLC is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.
#LI-Remote
Data Manager
US Remote
Emmes Group: Building a better future for us all.
Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.
We believe the work we do will have a direct impact on patients' lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We're looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us!
Primary Purpose
The Data Manager is responsible for data management activities for research studies. The Data Manager works as an integral part of a cross-functional team through the lifecycle of the research study from design through final analysis and study closeout. The Data Manager is responsible for the completeness and accuracy of the study data in the electronic database and collaborates with internal and external project teams on all aspects of data collection.
Responsibilities
Participates with cross-functional teams in design, documentation, testing, and implementation of clinical data collection studies in an electronic data capture (EDC) systemDesigns and/or develops study-specific electronic or paper Case Report Forms (CRFs), ensuring consistency with study protocol, clinical requirements, and accurate and efficient data collectionCollaborates with the project team and other study personnel to determine data collection requirements based on the study protocol and system knowledgeDocuments and resolves data management issues for a protocol or group of protocolsAssists with communication for internal and external teams to resolve data management issuesCreates or reviews data validation check specifications; coordinates with relevant parties in the development and testing of eCRF and data validation checksHelps organize project team meetings and facilitates efficient project communication to ensure deadlines are met; participates in department meetingsCreates and maintains study data management documents according to instructions (e.g. Data Management Handbook, Data Management Plan, Data Validation Plan, EDC System User's Guide, EDC Training and Certification Documents)Prepares data reports and assists with data presentations as applicableReviews data obtained through Electronic Medical Records (EMR) integration, commercially available EDC systems, or other external data sourcesMentors assigned employees on data management procedures and guidelinesIdentifies and resolves data queries and discrepancies; contributes to data quality metrics for a protocol or project; conducts data quality auditsConducts training for users on the EDC system and protocol-specific EDC requirements; maintains training documentation and manages system user accessOther duties as assignedQualifications
Bachelor's degree, preferably in a public health, clinical, science, technical, or related discipline; equivalent combination of education and relevant work experience may be considered in lieu of a degreeIncumbent typically will possess at least 2 years of data management experience (or Master's degree) and basic understanding of the clinical development and data management processesExperience in clinical electronic data capture (EDC) systems preferredKnowledge of Microsoft Office suite is essentialAbility to handle multiple tasks at one time and to work with minimal supervisionExcellent verbal and written communication skillsStrong attention to detail, adaptable, and flexibleWhy work at Emmes?
At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our
Emmes Cares
community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:
Flexible Approved Time OffTuition Reimbursement401k Retirement PlanWork From Home Anywhere in the USMaternal/Paternal LeaveCasual Dress Code & Work Environment
CONNECT WITH US!
Follow us on Twitter - @EmmesCRO
Find us on LinkedIn - Emmes
The Emmes Company, LLC is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.
#LI-Remote